Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

An opportunity has arisen for a QC Lab Manager (Micro) to join our team in Livingston based team on a 12 month fixed term contract.

Job Summary

To provide oversight and co-ordinate the routine running of the QC Microbiology. Provide technical expertise and guidance to support Sterility Assurance, Microbiology and Facility Contamination Control (FCC) initiatives on site.

Responsibilities

  • Ensure that EOHS requirements are met by the team, including individual/team training, and that any incidents are investigated and reported in a timely manner to the Head of Quality Control and the EOHS department.
  • To manage Microbiology activities in support of manufacturing schedules and support FCC activities
  • Oversee the execution of microbiology activities according to defined SOPs and protocols with timely reporting of issues to relevant staff
  • Provide support as Subject Matter Expert (SME) in microbiologically related investigations and other problem solving forums
  • Maintain knowledge and competence to undertake tasks within the team, for example, at times of absence or high workload
  • Ensure testing in the microbiology laboratories is scheduled and performed in a timely manner and in alignment with the Manufacturing Master Planning Schedule
  • Manage and maintain facilities, resources and equipment required to adequately support microbiology activities
  • Ensure direct reports are appropriately trained and competent in the procedures they are conducting, and are in compliance with cGMP working practices at all times
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Head of Quality Control, Head of Facility Contamination Control (FCC) and Qualified Person (QP)
  • Manage and co-ordinate on time delivery of QMS documentation by the team
  • Ensure the principles of Data Integrity are deployed within the team and that issues are escalated to the Head of Quality Control in a timely manner
  • Ensure high standards of housekeeping are maintained within areas of responsibility
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative team within QC
  • Develop, collate and report key quality/business related metrics, and use such metrics to drive a culture of continuous improvement and process efficiencies within areas of responsibility
  • Contribute, encourage and support staff development activities
  • To undertake any other duties as requested by the line manager in accordance with company requirements
  • Support shift and out of normal hours work, including weekends, as required to support business requirements
  • Deputise for the Head of QC during times of absence or a need for technical expertise

Expérience

  • Educated to degree level or equivalent experience
  • Experience within a QC Laboratory working to GMP within a recognised quality system (3+ years)
  • Knowledge of GMP guidelines and regulatory bodies
  • Previous supervisory experience in a lab environment preferred

Formation et Compétences

  • Ability to lead and co-ordinate work within a busy QC laboratory
  • Ability to motivate and engage an effective workforce
  • Ability to develop and manage change projects effectively and efficiently
  • Effective communication and presentation skills (for internal and external interactions)

Valneva is a speciailty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

A full-time opportunity has arisen at Valneva Scotland for a QC Coordinator (Raw Materials) to join the team.

Job Summary

To execute defined and trained Quality Control department tests for the release of raw materials, intermediate products and final products according to defined procedures and protocols and according to best cGMP work practices, Quality Standards and metrics, as well as assisting in the implementation and maintenance of policies for Quality Control department within Valneva. Carry out laboratory tasks as identified by QC department.

Responsibilities

  • Execute analytical procedures, for testing of raw materials, intermediate products and final products, according to defined SOPs and protocols
  • Apply best cGMP work practices and techniques to test and release raw materials and product within specification
  • Ensure that all necessary training is complete in the procedures conducted, and operate in compliance with best cGMP working practices at all times
  • Conduct on-time reporting according to the defined and trained document management standards including review and verification of analytical data
  • Immediately escalate and report any deviations to materials, facilities, processes or procedures to the Laboratory Manager
  • Be accountable for the analytical laboratories being clean, tidy and well organised and in a state of continuous inspection readiness
  • Conduct all activities in the most careful and safe manner and in full compliance with HSE requirements
  • Ensure that equipment, facilities and materials used in the QC laboratories comply with defined standards
  • Support change controls, investigations and CAPA’s in the post diligent manner
  • Identify areas for continuous improvement and escalate those to the Head of QC
  • Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting
  • Maintain adequate stocks of materials and equipment and laboratory consumables
  • Assist in monitoring and maintaining calibration status of all equipment within the Quality Control department
  • Calibration of pipettes and informing relevant personnel in a timely manner of any failure of calibration
  • Assist in ensuring adequate stocks of material and equipment for effective operation of laboratories
  • Storage of in process and final products samples including for stability and retention purposes
  • Preparation of SOPs (where applicable) in accordance with Valneva Quality systems
  • Perform filing duties and other QC administrative duties as required by the laboratory manager or Head of QC
  • To undertake any other duties as requested by the line manager in accordance with company requirements

Experience includes:

  • Degree in chemical/biological sciences or relevant experience
  • Knowledge of usage of Pharmacopoeias
  • Knowledge of GMP guidelines and regulatory bodies
  • Experience in method validation / verification is beneficial but not essential
  • Experience of Quality Management Systems
  • Experience in working with Microsoft Excel, and ERP systems
  • Experience of working to deadlines and managing conflicting priorities
  • Experience working effectively in a team, influencing as appropriate

Skills required:

  • Attention to detail
  • Excellent organisational skills
  • Effective communication skills
  • Flexible and adaptable team player
  • Ability to think analytically

Valneva ist ein Impfstoffunternehmen, das sich auf die Prävention von Infektionskrankheiten mit hohem ungedecktem medizinischen Bedarf spezialisiert hat. Valnevas Portfolio beinhaltet zwei am Markt befindliche Reiseimpfstoffe sowie verschiedene Impfstoffe in Entwicklung, darunter einzigartige Impfstoffe gegen Covid-19, Borreliose und Chikungunya.

IHRE AUFGABEN

  • Prüfung von Freigabe- und Stabilitätsmustern für Marktprodukte mit diversen analytischen Methoden (ELISA, HPLC, UV/VIS Spektro-Photometrie, zellbasierte Assays, ICP-OES etc.)
  • Sicherstellung der Einhaltung von SOPs und allen relevanten regulatorischen und gesetzlichen Anforderungen
  • Kultivierung eukaryotischer Zellen und Durchführung zellbasierter Assays
  • Überprüfung, Revision und Verifizierung analytischer Daten
  • Erstellung, Revision und Überprüfung der GMP-relevanten Dokumenten (zB Abweichungen, Änderungen, etc.)
  • Aktive Teilnahme an Laboruntersuchungen und deren Dokumentation
  • Übernahme der Verantwortung für Laborausrüstung inkl. deren Qualifizierung und Beaufsichtigung der regelmäßigen Reinigung, Kalibrierung und Wartung

IHRE FÄHIGKEITEN

  • Abgeschlossene HTL/FH/Universität in einem relevanten wissenschaftlichen Feld mit praktischer Erfahrung in einem GxP-regulierten Umfeld
  • Zumindest 4 Jahre Erfahrung im Laborbereich und ausgezeichnete Laborfertigkeiten (Zellkultur, immunologische Assays)
  • Erfahrung in der Erstellung von SOPs und GMP/GDP-Dokumen­tationen
  • Erfahrung mit der Instandhaltung und Wartung von Laborequipment von Vorteil
  • Bereitschaft zur Arbeit unter BSL-3 Bedingungen von Vorteil
  • Genauer Arbeitsstil und ausgezeichnete Kommunikationsfähigkeiten
  • Teamplayer/in mit hoher, sozialer Kompetenz
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Fähigkeit, in einem schnell wachsenden, internationalen Umfeld an unterschiedlichen Projekten zu arbeiten

UNSER ANGEBOT

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Zahlreiche, attraktive Benefits

Für diese Position bieten wir Ihnen ein marktkonformes Gehalt, das sowohl Ihren Qualifikationen als auch Ihrer bisherigen beruflichen Erfahrung entspricht. Aus gesetzlichen Gründen weisen wir jedoch darauf hin, dass ein Mindestgehalt von EUR 40.000,- brutto pro Jahr (Vollzeitbasis) gilt.

IHRE AUFGABEN

  • Prüfung von Freigabe- und Stabilitätsmustern für Marktprodukte mit diversen analytischen Methoden (ELISA, HPLC, UV/VIS Spektro-Photometrie, zellbasierte Assays, ICP-OES etc.)
  • Sicherstellung der Einhaltung von SOPs und allen relevanten regulatorischen und gesetzlichen Anforderungen
  • Kultivierung eukaryotischer Zellen und Durchführung zellbasierter Assays
  • Überprüfung analytischer Daten
  • Erstellung, Revision und Überprüfung von GMP-relevanten Dokumenten (zB Standardarbeitsvorschriften, Abweichungen, Änderungen, etc.)
  • Aktive Teilnahme an Laboruntersuchungen und deren Dokumentation
  • Übernahme der Verantwortung für Laborausrüstung inkl. deren Qualifizierung und Beaufsichtigung der regelmäßigen Reinigung, Kalibrierung und Wartung

IHRE FÄHIGKEITEN

  • Abgeschlossene HTL/FH/Universität in einem relevanten wissenschaftlichen Feld mit praktischer Erfahrung in einem GxP-regulierten Umfeld
  • Mehrjährige Erfahrung im Laborbereich und ausgezeichnete Laborfertigkeiten (Zellkultur, immunologische Assays)
  • Erfahrung mit der Instandhaltung und Wartung von Laborequipment ist von Vorteil
  • Bereitschaft zur Arbeit unter BSL-3 Bedingungen ist von Vorteil
  • Erfahrung in der Erstellung von SOPs und GMP/GDP-Dokumen­tationen ist von Vorteil
  • Genauer Arbeitsstil und ausgezeichnete Kommunikationsfähigkeiten
  • Teamplayer/in mit hoher, sozialer Kompetenz
  • Ausgezeichnete Englischkenntnisse in Wort und Schrift
  • Fähigkeit, in einem schnell wachsenden, internationalen Umfeld an unterschiedlichen Projekten zu arbeiten

UNSER ANGEBOT

  • Offene, wertschätzende Unternehmenskultur mit Innovationsgeist
  • Internationales, kollegiales Arbeitsumfeld mit flachen Hierarchien
  • Spannendes Tätigkeitsfeld mit der Möglichkeit der persönlichen Weiterentwicklung
  • Zahlreiche, attraktive Benefits wie Gleitzeit, Sodexo-Essensgutscheine, leistungsorientierter Bonus, etc.

Für diese Position bieten wir Ihnen ein marktkonformes Gehalt, das sowohl Ihren Qualifikationen als auch Ihrer bisherigen beruflichen Erfahrung entspricht. Aus gesetzlichen Gründen weisen wir jedoch darauf hin, dass ein KV-Mindestgehalt von EUR 34.000,- brutto pro Jahr (Vollzeitbasis) gilt.

Valneva est une société spécialisée dans le développement et la commercialisation de vaccins prophylactiques contre des maladies infectieuses générant d’importants besoins médicaux. Le Groupe a mis à profit son expertise et ses infrastructures pour commercialiser avec succès deux vaccins et pour faire rapidement progresser un large éventail de candidats vaccins en développement clinique, et notamment ses candidats vaccins contre la maladie de Lyme, le virus du chikungunya et la COVID-19.

YOUR RESPONSIBILITIES

  • Management of QC Analytics. Lead lab team (approx. 6 team members)
  • Implement and validate assays required for GMP release and stability testing according to relevant guidelines (e.g. ICH, FDA; EP, AMBO)
  • Supervise qualification/maintenance of equipment required for GMP release and stability testing according to relevant guidelines (e.g. ICH, FDA; EP; AMBO)
  • Planning and/or supervision of GMP testing including trouble shooting and data analysis.
  • Ensure efficient daily operations by coordinating resource allocations cross functions as needed.
  • Continues process improvements
  • Perform data review/approval/release required for release of raw materials, intermediate and final products
  • Maintain and ensure high quality of method performance
  • Create/review/approve Development Reports, Validation Protocols/Reports, SOPs & related documents
  • Issue, manage and close-out deviations, changes, investigations and CAPAs in a timely and independent manner

YOUR QUALIFICATIONS

Minimum requirements:

  • Completed master or PhD degree in Natural science studies (Biology, Chemistry, Biotechnology, etc.)
  • A minimum of four years GxP experience in the field of pharmaceutical production or quality control
  • Excellent analytical/problem solving skills
  • Excellent leadership, communication, organizational, documentation management and teamwork skills required
  • Good working knowledge of ICH/FDA/EMA/GMP and other applicable regulatory guidelines
  • Confident handling in MS Office
  • Very good German and good English skills
  • Accountability, decision making, ability to work in a team

Desirable requirements:

  • Computerized system validation

OUR OFFER

  • Une culture d’entreprise ouverte et bienveillante avec un esprit d’innovation et des postes attractifs.
  • Environnement international avec des lignes hiérarchiques courtes
  • Bon esprit d’équipe dans une équipe très motivée.
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 50.000 gross per year based on full-time employment.

However our salaries are market oriented and in line with your qualifications and experience.